How do I randomise if I cannot access Sealed Envelope?

There may be rare occasions when you cannot access Sealed Envelope, either because of an issue with your internet access or down-time at Sealed Envelope. The trial coordinating centre should be prepared for this event and have a back-up procedure in place. This will usually be described in a randomisation SOP. Common strategies are:

  • Wait until the service is accessible again
  • If local access is the problem, ask a user with an administrative account (such as the trial manager) to perform the randomisation on behalf of the investigator
  • If randomisation cannot wait, for example because the treatment must be administered very soon after enrolment in the trial, perform a manual randomisation. This may involve phoning the trial coordinating centre to be issued with the next treatment from a predefined emergency randomisation list the centre has drawn up in advance.
  • Alternatively it may involve taking the next available vial/kit/treatment pack from stock in a double blind drug trial.
The appropriate strategies will vary by trial. If a manual randomisation is performed, an administrator account can be used to update the randomisation system when it becomes available again.
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